IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00430963
First received: February 1, 2007
Last updated: October 25, 2011
Last verified: October 2011

February 1, 2007
October 25, 2011
October 2006
April 2007   (final data collection date for primary outcome measure)
  • Investigator's assessment according to the Facial Wrinkle Scale (FWS) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Responder: FWS score of 0 or 1.
  • Patient's global assessment [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Responder: subjects with a score of at least 2+.
  • Investigator's assessment
  • Patient's assessment
Complete list of historical versions of study NCT00430963 on ClinicalTrials.gov Archive Site
  • Investigator's assessment according to FWS [ Time Frame: Day 7, 60, 90, and 120 ] [ Designated as safety issue: No ]
    Responder: FWS score of 0 or 1.
  • Patient's global assessment [ Time Frame: Day 7, 60, 90, and 120 ] [ Designated as safety issue: No ]
    Responder: subjects with a score of at least 2+.
Not Provided
Not Provided
Not Provided
 
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension [OLEX] Period of 120 days each.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Glabellar Frown Lines
  • Drug: IncobotulinumtoxinA (Xeomin) (20 Units)
  • Drug: Placebo
    Other Name: Placebo
  • Placebo Comparator: Placebo
    Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection
    Intervention: Drug: Placebo
  • Experimental: IncobotulinumtoxinA (Xeomin) (20 Units)
    IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection
    Intervention: Drug: IncobotulinumtoxinA (Xeomin) (20 Units)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
November 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

•Moderate to severe glabellar frown lines

Exclusion Criteria:

  • Previous insertion of permanent material in the glabellar area
  • Neuromuscular function disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00430963
MRZ 60201-0520/1
No
Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
Not Provided
Study Director: Medical Expert Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP